NDC 49963-630 Clophed

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
49963-630
Proprietary Name:
Clophed
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Portal Pharmaceutical
Labeler Code:
49963
Start Marketing Date: [9]
05-28-2010
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Flavor(s):
ORANGE (C73406)
VANILLA (C73421)

Product Packages

NDC Code 49963-630-04

Package Description: 118 mL in 1 BOTTLE

NDC Code 49963-630-15

Package Description: 15 mL in 1 BOTTLE

Product Details

What is NDC 49963-630?

The NDC code 49963-630 is assigned by the FDA to the product Clophed which is product labeled by Portal Pharmaceutical. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 49963-630-04 118 ml in 1 bottle , 49963-630-15 15 ml in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Clophed?

Do not exceed recommended dosage.Adults and children 12 years of age and over:2 teaspoonfuls every 6 to 8 hours, not to exceed 8 teaspoonfuls in a 24 hour periodChildren 6 to under 12 years of age:1 teaspoonful every 6 to 8 hours, not to exceed 4 teaspoonfuls in a 24 hour periodChildren under 6 years of ageConsult a doctor

Which are Clophed UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Clophed Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Clophed?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1048075 - chlophedianol HCl 12.5 MG / guaiFENesin 100 MG / phenylephrine HCl 5 MG in 5 mL Oral Solution
  • RxCUI: 1048075 - chlophedianol hydrochloride 2.5 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution
  • RxCUI: 1048075 - chlophedianol HCl 12.5 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral Solution

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".